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RespoKare RK-200-2001A-624C

by Innonix Technologies Limited

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840039200558 UDI-DI Date22 Jan 2021ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
RespoKare
Generic Name
Surgical/medical respirator, antimicrobial
Model / Reference
RK-200-2001A-624C
Primary DI / UDI-DI
00840039200558
FDA Product Code
OUK
GMDN Term
Surgical/medical respirator, antimicrobial
Device Class
Class II
Regulation Number
878.4040
GUDID distribution status
Not in Commercial Distribution

Other devices from Innonix Technologies Limited

Properties

  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No